AB0500 Efficacy and safety of tofacitinib (TOF) in patients with rheumatoid arthritisat 52 weeks in clinical practice

Objectives There are few long-term experience of TOF for Rheumatoid arthritis (RA) patients in clinical use. We evaluated 52 and 104 weeks efficacy and safety of TOF in patients with rheumatoid arthritis in clinical practice. Methods We enrolled 77 RA patients started to treat with TOF between December 2013 and November 2016 in our hospital. All patients received 5 mg of TOF twice daily. We evaluated clinical disease activity in composite measures (including Disease Activity Score 28(DAS28) -Erythrocyte (-ESR), – C-reactive protein (-CRP), Simple Disease activity Index (SDAI) and Clinical Disease Activity Index (CDAI)) every three months and adverse events (AEs) during 52 and 104 weeks after treatment with TOF. We estimated the drug survival rate with Kaplan-Meier survival analysis. Results The mean age of patients was 66.3 years and the duration of disease was 15.4 years. Fifty-four (74.0%) patients have positive rheumatoid factor (RF) and 59 (78.7%) patients have positive anti-citrullinated potein antibodies (ACPA). Twenty-three patients were biologic-nave and fifty-four patients have ever been treated with biologic DMARDs of whose mean number is 2.6 prior to TOF. Regarding the last biologic DMARDs: 14 patients have treat with TNF inhibitor (Infliximab, etanercept, adalimumab, golimumab, certolizumab-pegol), 30 patients with tocilizumab and 10 patients with abatacept. Twenty-three (29.9%) patients were treated with TOF without methotrextate (MTX). Disease activity at TOF start with measured with DAS28-ESR, DAS28-CRP, SDAI and CDAI were 5.15, 4.07, 23.3 and 21.5 respectively. The Drug survival rate at 24 weeks is 84.4% and that at 52 weeks is 73.8%. Twenty-seven patients have been treated with tofacinib over 104 weeks. Twelve patients was stopped to treat within initial 24 week, including due to adeverse events (n=5) and lack of efficacy (n=7). Analysed by last observation continued forward (LOCF) method, the mean of DAS-ESR decreased to 3.52 at 24 week and 3.59 at 52 week. CDAI decreased from 21.5 to 7.94 at 24 week and 7.93 at 52 week. Sixteen (20.8%) patients were remission as which defined less than 2.6 in DAS-ESR and 13 (16.9%) were low disease activity (LDA) as which defined less than 3.2 in DAS-ESR. In 23 patients without MTX, 6 (26.0%) and 5 (21.7%) have achieved remission and LDA at 52 W respectively. The adverse events due to which the patients had to be stopped to treat with TOF occurred in 20.6% of patients in initial 52 weeks. Infection was the most frequent AE to TOF, especially herpes zoster (7 patients). Six patients experienced herpes zoster within 6 month after treat with TOF. All of them could restart to treatment of TOF. Two solid tumours were discovered within 6 months after treatment, both of them had be removed by surgery and has not recurred. Conclusions Our study shows that TOF can be much effective clinically and have longer-lasting effectiveness. In our patients, herpes zoster was almost as frequent as reported in the phase III trials in Japan and we could retreat almost of them with TOF. Disclosure of Interest None declared